Hepatitis C Treatment in Underserved Populations

Chronic Hepatitis C Clinical Trial

Official title:

Hepatitis C Treatment in Underserved Populations

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01717560
• Other study ID #: 0308006281
• Status: Enrolling by invitation
• Phase: N/A
• First received: April 29, 2008
• Last updated: October 25, 2012
• Start date: February 2005
• Est. completion date: December 2020

Study information

• Verified date: October 2012
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine the feasibility, safety, and effectiveness of treating persons who are actively using illicit drugs for hepatitis C using a collaborative, multidisciplinary, integrated care model. We hypothesize that by maximizing facilitators and minimizing barriers to treatment we can enable drug users to receive effective treatment for hepatitis C.

Description:

This study examines the feasibility of integrated treatment for hepatitis C in active IDUs using a client-centered, multidisciplinary model that combines expert care in five domains: (a) antiviral pharmacotherapy for HCV infection; (b) substance abuse treatment; (c) psychiatric evaluation and treatment; (d) primary medical care; and (e) intensive, client-centered, case management. The Weill Cornell Medical College Center for the Study of Hepatitis C collaborates with community-based organizations providing services to injection drug users to provide multidisciplinary, integrated care using a model that combines the resources of culturally appropriate community-based agencies with those of a state-of-the-art tertiary care center.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: December 2020
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years or older

• Used heroin, cocaine, or injected other drugs for at least 1 year

• Have used heroin, cocaine and/or methamphetamine within the last 30 days

• Test positive for HCV antibody

• Are interested in being evaluated for HCV treatment

Exclusion Criteria:

• Persons who are obviously intoxicated, incoherent or otherwise unable to give informed consent are excluded from participation. Such persons may participate in the study if they return at a later date and are capable of providing informed consent.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Illicit Drug Use

Intervention

Other:
• Collaborative, multidisciplinary, integrated care
Collaborative, multidisciplinary, integrated care for hepatitis C multidisciplinary model that combines expert care in five domains: (a) antiviral pharmacotherapy for HCV infection; (b) substance abuse treatment; (c) psychiatric evaluation and treatment; (d) primary medical care; and (e) intensive, client-centered, case management.

Locations

Country	Name	City	State
United States	Center for the Study of Hepatitis C, Weill Medical College, Cornell University	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Brian Edlin	State University of New York - Downstate Medical Center, Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained virologic response, defined as an undetectable serum HCV RNA level 24 weeks after completion of antiviral therapy.	SVR is measured 24 weeks after completion of antiviral treatment	24 weeks after completion of antiviral treatment	No
Secondary	completion of medical and psychiatric evaluation for antiviral therapy		Patients are expected to complete medical and psychiatric evaluation within 3-6 months but it may take longer in some cases.	No
Secondary	initiation of antiviral therapy		Patients are expected to initiate antiviral therapy (or decide not to) within 3-6 months but it may take longer in some cases.	No
Secondary	adherence to antiviral therapy	Adherence is measured weekly during the duration of prescribed antiviral therapy. (Antiviral therapy is prescribed for up to 48 weeks, depending on the patient's characteristics, the regimen, and the response to therapy.)	Weekly up to 48 weeks	No
Secondary	completion of antiviral therapy		Completion is recorded at the time prescribed antiviral therapy is discontinued, whether that happens when the prescribed duration of therapy is complete or before. (Antiviral therapy is prescribed for up to 48 weeks, depending on the patient.)	No
Secondary	levels of alcohol and illicit drug use	Measured weekly during antiviral therapy and monthly before and after therapy for the duration of follow-up	Weekly up to 96 weeks	No
Secondary	entry into treatment for substance use	Measured monthly from study enrollment through 24 weeks subsequent to completing prescribed course of antiviral therapy	Monthly up to 24 months	No
Secondary	entry into treatment for another unaddressed medical or psychiatric condition	Measured monthly from study enrollment through 24 weeks subsequent to completing prescribed course of antiviral therapy	Monthly up to 24 months	No
Secondary	neuropsychiatric side effects, including depression and hostility/irritability	Measured monthly during prescribed course of antiviral therapy and for 24 weeks thereafter	Monthly up to 72 weeks	Yes
Secondary	treatment-limiting systemic, hematologic, or other side effects	Measured weekly during prescribed course of antiviral therapy and then monthly or quarterly thereafter (TSH, for example, is measured every 3 months during and after treatment)	Weekly up to 72 weeks	Yes
Secondary	other adverse events or adverse effects	Measured monthly during prescribed course of antiviral therapy or as patients bring adverse events or effects to attention of physicians or study staff	Monthly up to 72 weeks	Yes
Secondary	reinfection	Patients are monitored at 3-month intervals for reinfection. This will continue as long as possible after completion of antiviral therapy.	Quarterly up to 10 years	No